Showing papers in "Annals of surgery open in 2022"

Learning Curves in Open, Laparoscopic, and Robotic Pancreatic Surgery

Abstract: In Brief Export Objective: To depict and analyze learning curves for open, laparoscopic, and robotic pancreatoduodenectomy (PD) and distal pancreatectomy (DP). Background: Formal training is recommended for safe introduction of pancreatic surgery but definitions of learning curves vary and have not been standardized. Methods: A systematic search on PubMed, Web of Science, and CENTRAL databases identified studies on learning curves in pancreatic surgery. Primary outcome was the number needed to reach the learning curve as defined by the included studies. Secondary outcomes included endpoints defining learning curves, methods of analysis (statistical/arbitrary), and classification of learning phases. Results: Out of 1115 articles, 66 studies with 14,206 patients were included. Thirty-five studies (53%) based the learning curve analysis on statistical calculations. Most often used parameters to define learning curves were operative time (n = 51), blood loss (n = 17), and complications (n = 10). The number of procedures to surpass a first phase of learning curve was 30 (20–50) for open PD, 39 (11–60) for laparoscopic PD, 25 (8–100) for robotic PD (P = 0.521), 16 (3–17) for laparoscopic DP, and 15 (5–37) for robotic DP (P = 0.914). In a three-phase model, intraoperative parameters improved earlier (first to second phase: operating time –15%, blood loss –29%) whereas postoperative parameters improved later (second to third phase: complications –46%, postoperative pancreatic fistula –48%). Studies with higher sample sizes showed higher numbers of procedures needed to overcome the learning curve (rho = 0.64, P < 0.001). Conclusions: This study summarizes learning curves for open-, laparoscopic-, and robotic pancreatic surgery with different definitions, analysis methods, and confounding factors. A standardized reporting of learning curves and definition of phases (competency, proficiency, mastery) is desirable and proposed. Mini Abstract: Learning curves in pancreatic surgery have not been systematically evaluated and standardized. This systematic review summarizes learning curves for open-, laparoscopic-, and robotic pancreatic surgery with different definitions, analysis methods, and confounding factors. A standardized reporting of learning curves and definition of phases (competency, proficiency, mastery) is proposed.

Comment on “Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence”

Abstract: To the Editor, We read with interest the article by Koedam et al.1 demonstrating anastomotic leakage as an independent risk factor for local recurrence after rectal cancer surgery. We congratulate the authors and agree that COLOR trial2 was not powered to be able to extrapolate data on anastomotic leaks and also how in a pre-FOLFOX era the outcomes of stage III colon cancer remained the same irrespective of chemotherapy. However, with respect to the COLOR II observations,3 we have the following concerns. The authors have noted that an ileostomy was performed in 52.4% (44/84) of patients with an anastomotic leak but we observe that “ileostomy” was not included as a factor in the univariate analysis for local recurrence at 5-years follow-up. In COLOR II, performing a diverting ileostomy was left to the discretion of the operating surgeon without being part of a protocol. As seen in COLOR II, preoperative radiation may lead to the increased rate of anastomotic leaks3,4 and not doing a diverting ileostomy can exaggerate sub-clinical leaks which would have not manifested otherwise.5,6 If anastomotic leaks increase the local recurrence,1,7 then the very purpose of neoadjuvant radiation to improve local control in rectal cancers would be defeated. In today’s era, to facilitate the timely administration of the adjuvant treatment and hence further decrease the recurrence rates, an ileostomy may at times prove beneficial. The authors, in the discussion, propose that increased recurrences after anastomotic leaks may be attributed to a delay in adjuvant chemotherapy (although rightly stated as not applicable to COLOR II). This reasoning may have been applicable if there were an increase in distant recurrences in addition to the local recurrences, which is not the case. The authors have referred to a hypothesis of spillage of cancer cells into the peritoneal cavity during the surgery and adhesion of tumor cells due to the inflammatory response of the leak. If this hypothesis is to be believed then the incidence of distant peritoneal failure should also be seen along with or apart from local recurrences. Anastomotic leaks in this analysis were not seen to cause seeding of distant peritoneal sites. Also, we observe that 5 of 23 patients (25.2%) with positive resection margins had a local recurrence at 5 years and 9 of 84 patients (13.3%) with anastomotic leaks had a local recurrence at 5 years. However, it would be interesting to note how many patients with positive resection margins had anastomotic leaks. We are not sure what could be the likely explanation for the increased recurrences in patients who had anastomotic leaks but this finding gives grounds to further evaluate total neoadjuvant treatment to treat rectal cancers,8 other than evaluating this important observation in a trial powered to study the same.

Xenogeneic Mesh Provides Safe and Durable Long-Term Outcomes in Abdominal Wall Reconstruction of High-Risk Centers for Disease Control and Prevention Class III and IV Defects

Abstract: Objective: Evaluate long-term outcomes of abdominal wall reconstruction (AWR) using xenogeneic mesh in patients with Centers for Disease Control and Prevention (CDC) class III/IV defects. We hypothesized that AWR with xenogeneic mesh results in acceptable outcomes. Background: Optimal mesh selection in AWR of CDC class III/IV defects is controversial. Outcomes using xenogeneic mesh are lacking. Methods: We conducted a retrospective cohort study of patients who underwent AWR using xenogeneic mesh in CDC class III/IV defects from March 2005 to June 2019. Primary outcome was hernia recurrence (HR). Secondary outcomes were surgical site occurrence (SSO) and surgical site infection (SSI). Results: Of consecutive 725 AWRs, we identified 101 patients who met study criteria. Sixty-eight patients had class III defects, while 33 had class IV defects. Patients had a mean age of 61.3 ± 11.1 years, mean body mass index of 31.8 ± 7.3 kg/m2, and mean follow-up time of 41.9 ± 26.3 months. Patients had HR rate of 21%, SSO rate of 49%, and SSI rate of 24. Class IV defects were predictive of SSOs (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.11–7.42; P = 0.029) but not HR (hazard ratio, 1.60; 95% CI, 0.59–4.34; P = 0.355) or SSIs (OR, 2.62; 95% CI, 0.85–8.10; P = 0.094). Conclusions: Patients with class IV defects have a higher risk of SSOs, but not HR or SSIs, compared with patients with class III defects. Despite the high level of defect contamination, AWR with xenogeneic mesh demonstrated acceptable HR, SSO, and SSI rates. Therefore, safe and durable long-term outcomes are achievable in single-stage AWR using xenogeneic mesh for CDC class III/IV defects.

Breast-Conserving Surgery or Mastectomy?

Abstract: In Brief Introduction: The early randomized controlled trials revealed no differences in survival between breast-conserving surgery (BCS) and mastectomy. However, breast cancer treatment has undergone changes, and the results of recent population-based registry studies suggest superior long-term survival after BCS. To explore the current evidence, a systematic review and meta-ana lysis of population-based observational studies from 2010 and onward was conducted. Methods: A literature search was conducted in the PubMed, Embase, and Cochrane databases to identify relevant literature. Keywords included “mastectomy,” “breast conserving surgery,” and “survival.” The identified studies were narratively reviewed and effect sizes (hazard ratios [HRs]) for overall (OS) and breast cancer-specific survival (BCSS) were combined with random-effects models. Results: A total of 30 reports were included in the review, and results from 25 studies were included in the meta-analyses. Compared with mastectomy, BCS was associated with better OS (HR = 1.34 [1.20–1.51]; N = 1,311,600) and BCSS (HR = 1.38 [1.29–1.47]; N = 494,267). Selected subgroups of patients, based on lymph node status, age (<50 years/≥50 years), and radiation therapy after mastectomy (±), all showed better overall survival after BCS. The number (range 4–12) and type of prognostic variables adjusted for in the survival analyses of the studies did not statistically significantly moderate the differences in survival between BCS and mastectomy. Conclusions: The combined findings from large population-based studies indicate that BCS is associated with survival benefit compared with mastectomy, suggesting that BCS be the recommended treatment of early breast cancer (T1-2N0-1M0) if a radical lumpectomy can be performed. Mini-Abstract: A systematic review and meta-analysis of population-based observational studies comparing the survival after breast-conserving surgery and mastectomy in patients with breast cancer. The review comprises 30 papers from 2010 to 2021. More than 1.3 million patients are included in the meta-analyses.

Underutilization of Guideline-Concordant Smoking Cessation Treatments in Surgical Patients: Lessons From a Learning Health System

Abstract: While smoking is a well-established risk factor for surgical complications, it is unclear how frequently guideline-concordant tobacco treatments are prescribed to surgical patients. In this cross-sectional study including 164673 unique patients evaluated in outpatient surgery clinics at a single institution in 2020, despite a relatively high smoking prevalence (14.7%), guideline-concordant treatment rates were very low, with only 12.7% of patients receiving pharmacotherapy and 31.7% receiving any treatment. Addressing disparities in smoking cessation treatments are critical given the disproportionate impact of smoking on surgical outcomes.

Coaching for Surgeons: A Scoping Review of the Quantitative Evidence

Abstract: Objective: To characterize quantitative studies on coaching interventions for professional surgeons to understand how surgical coaching is defined; examine how different coaching programs are designed, implemented, and evaluated; and identify any relevant research gaps. Background: Surgical coaching is gaining attention as an approach that could help surgeons optimize performance and improve overall wellbeing. However, surgical coaching programs and definitions of coaching vary widely between studies. Methods: A systematic literature search of PubMed, Scopus, Web of Science, CENTRAL, clinicaltrials.gov, and WHO ICTRP was conducted according to the PRISMA-ScR framework to identify studies and registered clinical trials written in English. Original quantitative studies on coaching interventions for professional surgeons were included. Characteristics of the coachees, coaching programs, study designs, outcomes, and findings were charted and analyzed. Results: From 2589 references, 8 studies (6 published; 2 registered trials) met inclusion criteria. Published studies targeted technical or nontechnical skills, included 2–26 surgeons as coachees, and used coaches who were surgeons. Two studies demonstrated that surgeons react positively to coaching. Studies showed inconsistent effects on technical/nontechnical skills. Only two studies measured patient adverse events and reported no significant positive impacts. The registered randomized trials targeted surgeons’ physiological parameters or wellbeing and used professional coaches. These trials measure surgeon and patient outcomes. Conclusions: There is an emerging interest in coaching programs to improve surgeons’ performance by targeting their professional skills and personal factors. However, more randomized trials are needed to evaluate the impact of coaching interventions on patient outcomes and surgeon wellness.

Impact of Endoscopic Surgical Skill Qualification on Laparoscopic Resections for Rectal Cancer in Japan: The EnSSURE Study

Abstract: Objective: This cohort study investigated short- and long-term postoperative outcomes of laparoscopic procedures for rectal cancer performed with versus without certified surgeons. Background: In Japan, the Endoscopic Surgical Skill Qualification System (ESSQS) evaluates surgical skills deemed essential for laparoscopic surgery; however, it is unknown whether this certification contributes to procedural safety. Methods: Outcomes of laparoscopic rectal resections for cStage II and III rectal cancer performed from 2014 to 2016 at 56 Japanese hospitals were retrospectively reviewed. The impact of having versus not having certified surgeons on postoperative complications and other short- and long-term outcomes were assessed. In cases with ESSQS-certified surgeons, surgeons attended surgery in the capacity of an operator, assistant, scope operator, or advisor. Results: Overall, 3188 procedures were analyzed, with 2644 procedures performed with and 544 without ESSQS-certified surgeons. A multivariate logistic regression model showed that the adjusted odds ratio of postoperative complications after procedures performed with ESSQS-certified surgeons was 0.68 (95% confidence interval, 0.51–0.91; P = 0.009). The adjusted odds ratios for conversion and pathological R0 resection rates with ESSQS-certified surgeons were 0.20 (P < 0.001) and 2.10 (P = 0.04), respectively. Multiple linear regression analyses showed significantly shorter surgical duration and more harvested lymph nodes for operations performed with ESSQS-certified surgeons. Multivariate Cox regression showed that the adjusted hazard ratios for poor overall and recurrence-free survival after operations performed with ESSQS-certified surgeons were 0.88 (P = 0.35) and 1.04 (P = 0.71), respectively. Conclusions: This study showed the superiority of the short-term postoperative results for laparoscopic rectal procedures performed with ESSQS-certified surgeons.

The History of Surgical Education in the United States: Past, Present, and Future

Abstract: In just over 100 years, surgical education in the United States has evolved from a disorganized practice to a refined system esteemed worldwide as one of the premier models for the training of physicians and surgeons. But in the changing environment of health care, new challenges have arisen that could warrant a reform. To design our future, we must understand our past. The present work is not intended to be a comprehensive account of the history of American surgery. Instead, it tells the abridged history of surgical education in our country: the evolution from apprenticeships to residencies; the birth of hospital-based teaching; the impact of key historical events on training; the marks left by some preeminent characters; the conception of regulatory entities that steer our education; and, finally, how our process of training surgeons might need to be refined for the continued progress of our profession. Told in chronological order in a manner that will be memorable to readers, this story weaves together the key events that explain how our current surgical training models came to be. We conclude with a timely invitation to draw from these past lessons to redesign the future of graduate medical education, making a case for the transition to time-variable, competency-based medical education for surgical residency programs in America.

Complexity-Adjusted Learning Curves for Robotic and Laparoscopic Liver Resection

Abstract: In Brief Background: Minimally invasive liver surgery (MILS) has a high variance in the type of resection and complexity, which has been underestimated in learning curve studies in the past. The aim of this work was to evaluate complexity-adjusted learning curves over time for laparoscopic liver resection (LLR) and robotic liver resection (RLR). Methods: Cumulative sum analysis (CUSUM) and complexity adjustment were performed using the Iwate score for LLR and RLR (n = 647). Lowest point of smoothed data was used to capture the cutoff of the increase in complexity. Data were collected retrospectively at the Department of Surgery of the Charité-Universitätsmedizin Berlin. Results: A total of 132 RLR and 514 LLR were performed. According to the complexity-adjusted CUSUM analysis, the initial learning phase was reached after 117 for LLR and 93 procedures for RLR, respectively. With increasing experience, the rate of (extended) right hemihepatectomy multiplied from 8.4% to 18.9% for LLR (P = 0.031) and from 21.6% to 58.3% for RLR (P < 0.001). Complication rates remained comparable between both episodes for LLR and RLR (T1 vs T2, P > 0.05). The complexity-adjusted CUSUM analysis demonstrated for blood transfusion, conversion, and operative time an increase during the learning phase (T1), while a steady state was reached in the following (T2). Conclusions: The learning phase for MILS after adjusting for complexity is about 4 times longer than assumed in previous studies, which should urge caution. Mini-abstract: Minimally invasive liver surgery has a high variance in the type of resection and complexity, which has been underestimated in learning curve studies in the past. Interestingly, the learning phase after adjusting for complexity is about four times longer than assumed in previous studies, which should urge caution.

Comment on The Unbearable Lightness of Difference Between Statistical and Clinical Significance

Abstract: In the latest issue of Annals of Surgery, Jin et al compared the efficacy of robotic-assisted (RATS) lobectomy and video-assisted (VATS) lobectomy in a single-center, open-label, parallel-arm noninferiority randomized clinical trial. They concluded that both approaches were safe and feasible, but RATS resulted in a more significant number of lymph nodes harvested.1 These results partially confirm the findings of a recent meta-analysis, where RATS was demonstrated as a feasible and safe technique with surgical efficacy comparable to VATS.2 The short-term results of the RVlob Trial are that the total number of lymph nodes dissected (11 vs 10) and the number of nodal stations examined were greater with RATS than with VATS (6 vs 5). Additionally, a more significant number of lymph nodes were dissected in N1 stations (6 vs 5) whether N2 stations remained constant (5 in both approaches).1 A previous meta-analysis showed that the number of dissected lymph nodes number comparing RATS with VATS does not reach a statistically significant level (>10 lymph nodes dissected).2 Nevertheless, it was demonstrated that examining more lymph nodes increases the likelihood of proper staging and influences the patient outcome. This information is critical for individual treatment and prognosis and for identifying those who benefit from adjuvant therapy.3 It was demonstrated that patients who undergo pulmonary lobectomy or pneumonectomy should have at least 12 lymph nodes examined.4 Nevertheless, when interpreting clinical evidence, 3 questions should be asked: How trustworthy are the findings? Are the results purely coincidental? Are the results meaningful to patient?5 Most journals now endorse the extension of the CONSORT 2019 statement for reporting noninferiority and equivalence randomised trials.6 Nonetheless, a common pitfall of this and other trial reports is the misinterpretation of statistical significance as clinical significance. The misunderstanding stems from the fact that many people associate significance with its literal meaning of significance, whereas in statistics, it has a much more restrictive connotation. In clinical practice, the clinical significance of study results is determined by their implications for current practice, with treatment effect size being one of the primary factors influencing treatment decisions. Clinical significance should be determined by the magnitude of the change, its effect on subject lives, the duration of the effects, consumer acceptability, cost-effectiveness, and ease of implementation. While established, traditionally accepted values exist for statistical significance testing, they do not exist for clinical significance evaluation. Often, the clinician’s judgment determines whether a result is clinically significant or not.7 Therefore, even statistically significant, the reported difference of only one lymph node dissected in the different nodal stations is clinically insignificant. Among the secondary endpoints of the evaluation, the authors considered direct and indirect costs of the hospitalisation. According to widely used guidelines for the economic evaluation of healthcare interventions, direct costs include all costs directly related to the intervention of interest, borne inside the healthcare sector (eg, materials, equipment, personnel, and services) as well as outside the healthcare sector (eg, patients’ travel time). Indirect costs include a temporary absence from work due to illness, reduced working capacity due to illness and disability, or lost productivity due to early death. While there is an increasing interest toward measuring the indirect costs of healthcare treatments to quantify the value of innovative therapies from a broader societal perspective, what the authors report as indirect costs, does not cover this evidentiary gap. Indeed, the level of details provided on the cost analysis (eg, lack of reporting of monetary unitary values and their sources) is not sufficient to appraise the methodological quality of findings about the direct costs either.8 In any case, Jin et al conclude that hospitalisation and indirect costs were significantly higher in the RATS without a statistically significant difference in direct costs between minimally invasive approaches. Given the relatively anticipated high cost of the robotic approach, it was reasonable to consider the cost performance index when selecting the minimally invasive approach.1 RATS was estimated to cost more than VATS and open surgery, with a profit margin of 18% compared with the Italian health service reimbursement. Cost estimates for robotic surgery were 82% of lobectomy reimbursement, 69% for open surgery, and 68% for VATS. Nevertheless, the current high cost of RATS is concerning and may limit its adoption by European thoracic surgeons. However, the approach was profitable because it cost approximately 18% less than the current reimbursement for Italian health services.9 In conclusion, we should keep in mind that the clinical significance of study results should be determined by examining the actual treatment effect (with confidence intervals) and should not be based solely on P values and statistical significance. Before conducting the study, researchers should be more vigilant in using outcome measures that have a defined minimal clinically important difference or define a minimal clinically important difference. If the outcome of interest does not have a defined minimum clinically important difference, then researchers should be wary of simply interpreting results as significant based on a P value without considering the clinical impact of the findings.10

The Safety Profile of Hepatectomy Following Preoperative Systemic Therapy with Lenvatinib Plus Anti-PD-1 Antibodies Versus Hepatectomy Alone in Patients With Hepatocellular Carcinoma

Abstract: In Brief Objective: To determine the safety of hepatectomy after combined lenvatinib and anti-PD-1 preoperative systemic therapy (PST) in patients with marginally resectable hepatocellular carcinoma (HCC). Background: PST followed by hepatectomy (PSTH) is an emerging treatment for HCC. However, the impact of PST with lenvatinib plus anti-PD-1 antibodies on surgical safety is unknown. Methods: Medical records from consecutive patients with marginally resectable advanced HCC who underwent hepatectomy after PST with lenvatinib and anti-PD-1 antibodies between January 2018 and August 2021 were retrieved from a prospectively designed database. Propensity score matching (1:2) was performed with a further 2318 HCC patients who underwent upfront hepatectomy (UH) without initial antitumor treatment during the same period. Results: In total, 49 and 98 matched patients were included in the PSTH and UH groups, respectively. Compared to the UH group, individuals in the PSTH group experienced more intraoperative blood loss, blood transfusions, and longer postoperative hospital stays. Moreover, posthepatectomy liver failure was more common in the PSTH group, who also had worse albumin-bilirubin (ALBI) scores on postoperative days 1–7. A significantly greater amount of drainage was also required in the PSTH group. However, the 30-day morbidity and 90-day mortality were similar among the two groups. Additionally, the duration of surgery, use of hepatic inflow occlusion during surgery, and the levels of postoperative inflammation-based markers were not statistically different between the two groups. Conclusions: Despite more intraoperative and postoperative adverse events, PSTH had comparable 30-day morbidity and 90-day mortality as UH. Thus, PSTH appears to be a viable treatment option for marginally resectable HCC patients with careful preoperative evaluation. Mini-abstract: This propensity score-matched study assessed the safety of combined lenvatinib and anti-PD-1 preoperative systemic therapy prior to hepatectomy (PSTH), compared to upfront hepatectomy (UH), in patients with hepatocellular carcinoma. Despite more adverse events in the PSTH group, the 30-day morbidity and 90-day mortality rates were similar for both groups.

Extent of Disease on Visceral Peritoneal Surfaces of Mucinous Appendiceal Neoplasms Controls Survival

Abstract: Objective: To determine causes of treatment failure of low-grade appendiceal mucinous neoplasms (LAMN). Background: For 3 decades, LAMN have been treated by cytoreductive surgery (CRS) and perioperative intraperitoneal chemotherapy. This combined treatment has resulted in a large change in the survival of these patients. Methods: A retrospective review of a prospectively maintained database was performed. A restricted cohort of patients with only LAMN histology and complete CRS were included in the statistical analysis. Results: Four hundred and fifty patients were available with a median follow-up of 15.3 years (range 10–35 years). The median age was 49.7 and there were 196 males (43.6%). The mean survival was 24.5 years. Extent of parietal peritonectomy, resection of uterus, ovaries and apex of vagina had no impact on survival. Variables that indicated an increased extent of disease on visceral peritoneal surfaces had a significant impact on survival. Early postoperative intraperitoneal chemotherapy with 5-fluorouracil did not augment hyperthermic intraperitoneal chemotherapy (HIPEC). Patients who required reoperation for recurrence or patients with class 4 adverse events had a reduced prognosis. Conclusions: The mean survival of LAMN treated by complete CRS and perioperative chemotherapy was 24.5 years. Extent of disease quantitated on visceral peritoneal surfaces by the extent of visceral resections was the variable associated with treatment failure. Peritonectomy plus HIPEC was able to control disease on parietal peritoneal surfaces. Not only a larger extent of disease but also its location on visceral peritoneal surfaces controlled survival.

nnU-Net Deep Learning Method for Segmenting Parenchyma and Determining Liver Volume From Computed Tomography Images

Abstract: Background: Recipient donor matching in liver transplantation can require precise estimations of liver volume. Currently utilized demographic-based organ volume estimates are imprecise and nonspecific. Manual image organ annotation from medical imaging is effective; however, this process is cumbersome, often taking an undesirable length of time to complete. Additionally, manual organ segmentation and volume measurement incurs additional direct costs to payers for either a clinician or trained technician to complete. Deep learning-based image automatic segmentation tools are well positioned to address this clinical need. Objectives: To build a deep learning model that could accurately estimate liver volumes and create 3D organ renderings from computed tomography (CT) medical images. Methods: We trained a nnU-Net deep learning model to identify liver borders in images of the abdominal cavity. We used 151 publicly available CT scans. For each CT scan, a board-certified radiologist annotated the liver margins (ground truth annotations). We split our image dataset into training, validation, and test sets. We trained our nnU-Net model on these data to identify liver borders in 3D voxels and integrated these to reconstruct a total organ volume estimate. Results: The nnU-Net model accurately identified the border of the liver with a mean overlap accuracy of 97.5% compared with ground truth annotations. Our calculated volume estimates achieved a mean percent error of 1.92% + 1.54% on the test set. Conclusions: Precise volume estimation of livers from CT scans is accurate using a nnU-Net deep learning architecture. Appropriately deployed, a nnU-Net algorithm is accurate and quick, making it suitable for incorporation into the pretransplant clinical decision-making workflow.

Single dose IV Antibiotic for Low-Energy Extremity Gunshot Wounds

Abstract: In Brief Objective: To prospectively determine infection rate following low-energy extremity GSWs with a single dose IV antibiotic protocol. Summary Background Data: Previous work suggests that a single IV antibiotic dose, without formal surgical debridement, mitigates infection risk. Methods: Over 35 months 530 adults with low-energy GSWs to the extremities were included. Three hundred fifty-two patients (66%) had ≥30 days follow-up. Patients were administered a single dose of first-generation IV cephalosporin antibiotics, and those with operative fractures received 24-hour perioperative antibiotics. Injury characteristics, treatment, protocol adherence, and outcomes (infection) were assessed between the protocol group (single-dose antibiotics) and the non-protocol group (no antibiotics or extra doses of antibiotics). Results: Compliance with the single-dose protocol occurred in 66.8%, while 33.2% received additional antibiotics or no antibiotics. The deep infection rate requiring surgical debridement was 0.8%, while the combined rate of all infections was 11.1%. Age, sex, injury location, multiple injuries, fracture presence, and type of surgery did not affect infection rate. Adherence to the antibiotic protocol was associated with a reduction in infection risk (odds ratio = 0.39, 95% confidence interval 0.19–0.83, P = 0.01). Receipt of additional antibiotics outside of our single-dose protocol did not predict further reduction in rate of infection (P = 0.64). Conclusions: A standardized protocol of single-dose IV antibiotic appears effective in minimizing infection after low-energy GSW to the extremities. Level of Evidence: Therapeutic Level II. A standardized protocol of single-dose IV antibiotic was implemented for 530 patients with low-energy extremity GSW. The deep infection rate requiring surgical debridement was 0.8%, while the combined rate of all infections was 11.1%. Except for antibiotic protocol compliance, demographic and injury factors including age, sex, injury location, fracture presence, and surgery type were not associated with lowering infection risk.

Radiocephalic Arteriovenous Fistula Patency and Use

Abstract: Objective: We sought to confirm and extend the understanding of clinical outcomes following creation of a common distal autogenous access, the radiocephalic arteriovenous fistula (RCAVF). Background: Interdisciplinary guidelines recommend distal autogenous arteriovenous fistulae as the preferred hemodialysis (HD) access, yet uncertainty about durability and function present barriers to adoption. Methods: Pooled data from the 2014-2019 multicenter randomized-controlled PATENCY-1 and PATENCY-2 trials were analyzed. New RC-AVFs were created in 914 patients, and outcomes were tracked prospectively for 3-years. Cox proportional hazards and Fine-Gray regression models were constructed to explore patient, anatomic, and procedural associations with access patency and use. Results: Mean (SD) age was 57 (13) years; 45% were on dialysis at baseline. Kaplan-Meier estimates of 3-year primary, primary-assisted, and secondary patency were 27.6%, 56.4%, and 66.6%, respectively. Cause-specific 1-year cumulative incidence estimates of unassisted and overall RC-AVF use were 46.8% and 66.9%, respectively. Patients with larger baseline cephalic vein diameters had improved primary (per mm, hazard ratio [HR] 0.89, 95% confidence intervals 0.81–0.99), primary-assisted (HR 0.75, 0.64–0.87), and secondary (HR 0.67, 0.57–0.80) patency; and higher rates of unassisted (subdistribution hazard ratio 1.21, 95% confidence intervals 1.02–1.44) and overall RCAVF use (subdistribution hazard ratio 1.26, 1.11–1.45). Similarly, patients not requiring HD at the time of RCAVF creation had better primary, primary-assisted, and secondary patency. Successful RCAVF use occurred at increased rates when accesses were created using regional anesthesia and at higher volume centers. Conclusions: These insights can inform patient counseling and guide shared decision-making regarding HD access options when developing an individualized end-stage kidney disease life-plan.

Risk Factors, Diagnosis and Management of Chyle Leak Following Esophagectomy for Cancers

Abstract: Objective: This Delphi exercise aimed to gather consensus surrounding risk factors, diagnosis, and management of chyle leaks after esophagectomy and to develop recommendations for clinical practice. Background: Chyle leaks following esophagectomy for malignancy are uncommon. Although they are associated with increased morbidity and mortality, diagnosis and management of these patients remain controversial and a challenge globally. Methods: This was a modified Delphi exercise was delivered to clinicians across the oesophagogastric anastomosis collaborative. A 5-staged iterative process was used to gather consensus on clinical practice, including a scoping systematic review (stage 1), 2 rounds of anonymous electronic voting (stages 2 and 3), data-based analysis (stage 4), and guideline and consensus development (stage 5). Stratified analyses were performed by surgeon specialty and surgeon volume. Results: In stage 1, the steering committee proposed areas of uncertainty across 5 domains: risk factors, intraoperative techniques, and postoperative management (ie, diagnosis, severity, and treatment). In stages 2 and 3, 275 and 250 respondents respectively participated in online voting. Consensus was achieved on intraoperative thoracic duct ligation, postoperative diagnosis by milky chest drain output and biochemical testing with triglycerides and chylomicrons, assessing severity with volume of chest drain over 24 hours and a step-up approach in the management of chyle leaks. Stratified analyses demonstrated consistent results. In stage 4, data from the Oesophagogastric Anastomosis Audit demonstrated that chyle leaks occurred in 5.4% (122/2247). Increasing chyle leak grades were associated with higher rates of pulmonary complications, return to theater, prolonged length of stay, and 90-day mortality. In stage 5, 41 surgeons developed a set of recommendations in the intraoperative techniques, diagnosis, and management of chyle leaks. Conclusions: Several areas of consensus were reached surrounding diagnosis and management of chyle leaks following esophagectomy for malignancy. Guidance in clinical practice through adaptation of recommendations from this consensus may help in the prevention of, timely diagnosis, and management of chyle leaks.

Endotheliopathy Is Associated With a 24-Hour Fibrinolysis Phenotype Described by Low TEG Lysis and High d-Dimer After Trauma

Abstract: Objectives: Determine associations between biomarkers of endotheliopathy, 24-hour fibrinolysis phenotypes and clinical outcomes after trauma. Background: The vascular endothelium is a critical regulator of hemostasis and organ function. The relationship between markers of endotheliopathy and fibrinolysis following trauma has not been evaluated. Methods: We performed a secondary analysis of prospectively collected biomarker data in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized controlled trial. We stratified subjects by 24-hour thromboelastography (TEG) percent clot lysis (LY30) and plasma d-dimer (DD) levels and evaluated differences in endotheliopathy biomarkers and clinical outcomes between subjects with one of four 24-hour fibrinolysis phenotypes: LY30 0.9% to 2.9% (LY30norm), LY30 > 2.9% (LY30high), LY30 < 0.9% and low DD (LY30low+DDlow), and LY30 < 0.9% and high DD (LY30low+DDhigh). Results: The analysis included 168 subjects with LY30norm, 32 with LY30high, 147 with LY30low+DDlow, and 124 with LY30low+DDhigh. LY30low+DDhigh subjects had greater injury severity and a higher incidence of severe head injury, multiorgan failure (MOF), and mortality than the other phenotypes. All endotheliopathy biomarkers were significantly higher in the LY30low+DDhigh phenotype. Adjusting for injury severity, mechanism, and head trauma, 24-hour angiopoietin-2 and soluble thrombomodulin were independently associated with the LY30low+DDhigh phenotype. Both endothelial biomarkers were discriminating for MOF. Subjects with thrombomodulin level >9.5 ng/mL and angiopoietin-2 level >3.6 ng/mL accounted for 64% of subjects who developed MOF. Conclusions: In a multicenter trauma cohort, subjects with a fibrinolysis phenotype characterized by low TEG lysis and elevated DD 24 hours after injury have significantly worse endotheliopathy and clinical outcomes. Our findings support mechanistic evaluations of the role of the endothelium in fibrinolysis dysregulation that may drive late-stage organ injury.

Coaching for Surgeons: A Scoping Review of the Quantitative Evidence

Abstract: To characterize quantitative studies on coaching interventions for professional surgeons to understand how surgical coaching is defined; examine how different coaching programs are designed, implemented, and evaluated; and identify any relevant research gaps.Surgical coaching is gaining attention as an approach that could help surgeons optimize performance and improve overall wellbeing. However, surgical coaching programs and definitions of coaching vary widely between studies.A systematic literature search of PubMed, Scopus, Web of Science, CENTRAL, clinicaltrials.gov, and WHO ICTRP was conducted according to the PRISMA-ScR framework to identify studies and registered clinical trials written in English. Original quantitative studies on coaching interventions for professional surgeons were included. Characteristics of the coachees, coaching programs, study designs, outcomes, and findings were charted and analyzed.From 2589 references, 8 studies (6 published; 2 registered trials) met inclusion criteria. Published studies targeted technical or nontechnical skills, included 2-26 surgeons as coachees, and used coaches who were surgeons. Two studies demonstrated that surgeons react positively to coaching. Studies showed inconsistent effects on technical/nontechnical skills. Only two studies measured patient adverse events and reported no significant positive impacts. The registered randomized trials targeted surgeons' physiological parameters or wellbeing and used professional coaches. These trials measure surgeon and patient outcomes.There is an emerging interest in coaching programs to improve surgeons' performance by targeting their professional skills and personal factors. However, more randomized trials are needed to evaluate the impact of coaching interventions on patient outcomes and surgeon wellness.

nnU-Net Deep Learning Method for Segmenting Parenchyma and Determining Liver Volume From Computed Tomography Images

Abstract: Recipient donor matching in liver transplantation can require precise estimations of liver volume. Currently utilized demographic-based organ volume estimates are imprecise and nonspecific. Manual image organ annotation from medical imaging is effective; however, this process is cumbersome, often taking an undesirable length of time to complete. Additionally, manual organ segmentation and volume measurement incurs additional direct costs to payers for either a clinician or trained technician to complete. Deep learning-based image automatic segmentation tools are well positioned to address this clinical need.To build a deep learning model that could accurately estimate liver volumes and create 3D organ renderings from computed tomography (CT) medical images.We trained a nnU-Net deep learning model to identify liver borders in images of the abdominal cavity. We used 151 publicly available CT scans. For each CT scan, a board-certified radiologist annotated the liver margins (ground truth annotations). We split our image dataset into training, validation, and test sets. We trained our nnU-Net model on these data to identify liver borders in 3D voxels and integrated these to reconstruct a total organ volume estimate.The nnU-Net model accurately identified the border of the liver with a mean overlap accuracy of 97.5% compared with ground truth annotations. Our calculated volume estimates achieved a mean percent error of 1.92% + 1.54% on the test set.Precise volume estimation of livers from CT scans is accurate using a nnU-Net deep learning architecture. Appropriately deployed, a nnU-Net algorithm is accurate and quick, making it suitable for incorporation into the pretransplant clinical decision-making workflow.

Endotheliopathy Is Associated With a 24-Hour Fibrinolysis Phenotype Described by Low TEG Lysis and High d-Dimer After Trauma

Abstract: Determine associations between biomarkers of endotheliopathy, 24-hour fibrinolysis phenotypes and clinical outcomes after trauma.The vascular endothelium is a critical regulator of hemostasis and organ function. The relationship between markers of endotheliopathy and fibrinolysis following trauma has not been evaluated.We performed a secondary analysis of prospectively collected biomarker data in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized controlled trial. We stratified subjects by 24-hour thromboelastography (TEG) percent clot lysis (LY30) and plasma D-dimer (DD) levels and evaluated differences in endotheliopathy biomarkers and clinical outcomes between subjects with one of four 24-hour fibrinolysis phenotypes: LY30 0.9-2.9% (LY30norm), LY30 >2.9% (LY30high), LY30 <0.9% and low DD (LY30low+DDlow), and LY30 <0.9% and high DD (LY30low+DDhigh).The analysis included 168 subjects with LY30norm, 32 with LY30high, 147 with LY30low+DDlow and 124 with LY30low+DDhigh. LY30low+DDhigh subjects had greater injury severity and a higher incidence of severe head injury, multiorgan failure (MOF), and mortality than the other phenotypes. All endotheliopathy biomarkers were significantly higher in the LY30low+DDhigh phenotype. Adjusting for injury severity, mechanism and head trauma, 24-hour angiopoietin-2 and soluble thrombomodulin were independently associated with the LY30low+DDhigh phenotype. Both endothelial biomarkers were discriminating for MOF. Subjects with thrombomodulin level >9.5 ng/mL and angiopoietin-2 level >3.6 ng/mL accounted for 64% of subjects who developed MOF.In a multicenter trauma cohort, subjects with a fibrinolysis phenotype characterized by low TEG lysis and elevated DD 24 hours after injury have significantly worse endotheliopathy and clinical outcomes. Our findings support mechanistic evaluations of the role of the endothelium in fibrinolysis dysregulation that may drive late-stage organ injury.

Universal Screening for Firearm Injury Risk Could Reduce Healthcare’s Hesistancy in Talking to Patients About Firearm Safety

Abstract: Despite vast long-standing healthcare industry support for a public health approach to firearm injury and mortality prevention - still -- the minority of physicians, surgeons, nurses, and social workers ask patients questions about firearm access or gun violence risk, let alone counsel about firearm safety.1,2 For most of us, screening and counselling related to firearm injury prevention, though demonstrated to be beneficial,3 continues to fall outside the umbrella of 'usual care' and is often reserved for patients deemed 'high risk' such as those presenting with suicidality, assault-related injuries or perceived risk.1,2,3 But for us to practice what we preach, a complete re-think using a novel, unconventional and non-discriminatory universal firearm injury risk screening approach across trauma, emergency, and primary care settings - for all patients regardless of reason for visit -- may be the transformative change needed to shift the paradigm. By asking each and every patient questions about firearm injury risk as part of routine surgical or medical care, we may finally be able to break down barriers and get comfortable talking to patients about firearm safety. After all, for any public health issue, it all starts with surveillance and screening. If we can't get comfortable asking the necessary questions in the first place, holistic progress from the healthcare lane on our nation's public health crisis of firearm injury and violence will continue to prove elusive.

Association of Insurance Type With Colorectal Surgery Outcomes and Costs at a Safety-Net Hospital

Abstract: Objective: Association of insurance type with colorectal surgical complications, textbook outcomes (TO), and cost in a safety-net hospital (SNH). Background: SNHs have higher surgical complications and costs compared to low-burden hospitals. How does presentation acuity and insurance type influence colorectal surgical outcomes? Methods: Retrospective cohort study using single-site National Surgical Quality Improvement Program (2013–2019) with cost data and risk-adjusted by frailty, preoperative serious acute conditions (PASC), case status and open versus laparoscopic to evaluate 30-day reoperations, any complication, Clavien-Dindo IV (CDIV) complications, TO, and hospitalization variable costs. Results: Cases (Private 252; Medicare 207; Medicaid/Uninsured 619) with patient mean age 55.2 years (SD = 13.4) and 53.1% male. Adjusting for frailty, open abdomen, and urgent/emergent cases, Medicaid/Uninsured patients had higher odds of presenting with PASC (adjusted odds ratio [aOR] = 2.02, 95% confidence interval [CI] = 1.22–3.52, P = 0.009) versus Private. Medicaid/Uninsured (aOR = 1.80, 95% CI = 1.28–2.55, P < 0.001) patients were more likely to undergo urgent/emergent surgeries compared to Private. Medicare patients had increased odds of any and CDIV complications while Medicaid/Uninsured had increased odds of any complication, emergency department or observations stays, and readmissions versus Private. Medicare (aOR = 0.51, 95% CI = 0.33–0.88, P = 0.003) and Medicaid/Uninsured (aOR = 0.43, 95% CI = 0.30–0.60, P < 0.001) patients had lower odds of achieving TO versus Private. Variable cost %change increased in Medicaid/Uninsured patients to 13.94% (P = 0.005) versus Private but was similar after adjusting for case status. Urgent/emergent cases (43.23%, P < 0.001) and any complication (78.34%, P < 0.001) increased %change hospitalization costs. Conclusions: Decreasing the incidence of urgent/emergent colorectal surgeries, possibly by improving access to care, could have a greater impact on improving clinical outcomes and decreasing costs, especially in Medicaid/Uninsured insurance type patients.

A Multicenter, Randomized, Double-Blinded, Clinical Trial Comparing Cattell-Warren and Blumgart Anastomoses Following Partial Pancreatoduodenectomy

Abstract: Objective: Whether a Blumgart anastomosis (BA) is superior to Cattell-Warren anastomosis (CWA) in terms of postoperative pancreatic fistula (POPF) following pancreatoduodenectomy. Importance: Complications driven by POPF following pancreatic cancer resection may hinder adjuvant therapy, shortening survival. BA may reduce complications compared to CWA, improving the use of adjuvant therapy and prolonging survival. Methods: A multicenter double-blind, controlled trial of patients undergoing resection for suspected pancreatic head cancer, randomized during surgery to a BA or CWA, stratified by pancreatic consistency and duct diameter. The primary end point was POPF, and secondary outcome measures were adjuvant therapy use, specified surgical complications, quality of life, and survival from the date of randomization. For a 10% POPF reduction, 416 patients were required, 208 per arm (two-sided α = 0·05; power = 80%). Results: Z-score at planned interim analysis was 0.474 so recruitment was held to 238 patients; 236 patients were analyzed (112 BA and 124 CWA). No significant differences in POPF were observed between BA and CWA, odds ratio (95% confidence interval [CI]) 1·04 (0.58–1.88), P = 0.887, nor in serious adverse events. Adjuvant therapy was delivered to 98 (62%) of 159 eligible patients with any malignancy; statistically unrelated to arm or postoperative complications. Twelve-month overall survival, hazard ratio (95% CI), did not differ between anastomoses; BA 0.787 (0.713–0.868) and CWA 0.854 (0.792–0.921), P = 0.266, nor for the 58 patients with complications, median (IQR), 0.83 (0.74–0.91) compared to 101 patients without complications 0.82 (0.76–0.89) (P = 0.977). Conclusions: PANasta represents the most robust analysis of BA versus CWA to date.

The Affordable Care Act and its Effects on Trauma Care Access, Short- and Long-term Outcomes and Financial Impact

Abstract: In Brief Objective: The purpose of this study is to evaluate the current evidence regarding the impact of the ACA on trauma outcomes and the financial impact on trauma patients and trauma systems. Background: Traumatic injuries are the leading cause of death and disability between the ages of 1 to 47 years. Uninsured status has been associated with worse outcomes and higher financial strain. The Affordable Care Act (ACA) was signed into law with the aim of increasing health insurance coverage. Despite improvements in insured status, it is unclear how the ACA has affected trauma. Methods: We conducted a literature search using PubMed and Google Scholar for peer-reviewed studies investigating the impact of the ACA on trauma published between January 2017 and April 2021. Results: Our search identified 20 studies that evaluated the impact of ACA implementation on trauma. The evidence suggests ACA implementation has been associated with increased postacute care access but not significant changes in trauma mortality. ACA implementation has been associated with a decreased likelihood of catastrophic health expenditures for trauma patients. ACA was also associated with an increase in overall reimbursement and amount billed for trauma visits, but a decrease in Medicaid reimbursement. Conclusions: Some improvements on the financial impact of ACA implementation on trauma patients and trauma systems have been shown, but studies are limited by methods of calculating costs and by inconsistent pre-/post-ACA timeframes. Further studies on cost-effectiveness and cost-benefit analysis will need to be conducted to definitively determine the impact of ACA on trauma. Mini Abstract: Affordable Care Act implementation has increased access to postacute care for trauma patients, which may improve long-term outcomes. Out-of-pocket expenses and catastrophic health expenditures appear to have decreased significantly and localized disproportionately to lowest- and low-income individuals. Evidence also suggests an increase in the amount billed by trauma centers but not necessarily the amount collected.

Association of Insurance Type With Colorectal Surgery Outcomes and Costs at a Safety-Net Hospital

Abstract: Association of insurance type with colorectal surgical complications, textbook outcomes (TO), and cost in a safety-net hospital (SNH).SNHs have higher surgical complications and costs compared to low-burden hospitals. How does presentation acuity and insurance type influence colorectal surgical outcomes?Retrospective cohort study using single-site National Surgical Quality Improvement Program (2013-2019) with cost data and risk-adjusted by frailty, preoperative serious acute conditions (PASC), case status and open versus laparoscopic to evaluate 30-day reoperations, any complication, Clavien-Dindo IV (CDIV) complications, TO, and hospitalization variable costs.Cases (Private 252; Medicare 207; Medicaid/Uninsured 619) with patient mean age 55.2 years (SD = 13.4) and 53.1% male. Adjusting for frailty, open abdomen, and urgent/emergent cases, Medicaid/Uninsured patients had higher odds of presenting with PASC (adjusted odds ratio [aOR] = 2.02, 95% confidence interval [CI] = 1.22-3.52, P = 0.009) versus Private. Medicaid/Uninsured (aOR = 1.80, 95% CI = 1.28-2.55, P < 0.001) patients were more likely to undergo urgent/emergent surgeries compared to Private. Medicare patients had increased odds of any and CDIV complications while Medicaid/Uninsured had increased odds of any complication, emergency department or observations stays, and readmissions versus Private. Medicare (aOR = 0.51, 95% CI = 0.33-0.88, P = 0.003) and Medicaid/Uninsured (aOR = 0.43, 95% CI = 0.30-0.60, P < 0.001) patients had lower odds of achieving TO versus Private. Variable cost %change increased in Medicaid/Uninsured patients to 13.94% (P = 0.005) versus Private but was similar after adjusting for case status. Urgent/emergent cases (43.23%, P < 0.001) and any complication (78.34%, P < 0.001) increased %change hospitalization costs.Decreasing the incidence of urgent/emergent colorectal surgeries, possibly by improving access to care, could have a greater impact on improving clinical outcomes and decreasing costs, especially in Medicaid/Uninsured insurance type patients.

Safe Technical Innovation

Abstract: INTRODUCTION In 2016, Sarfati et al1 described the feasibility of robotic-assisted nipple-sparing mastectomy (RNSM) in a cohort of 4 cadaveric breasts. During the ensuing years, surgeons, predominately in Europe and Asia, have developed innovative techniques to explore the utility of RNSM. Early adopters of RNSM cite superior visualization, greater stability with tremor elimination, enhanced precise movement with more degrees of freedom, better access to small or difficult to reach spaces, and improved ergonomics compared with traditional nipple sparing mastectomy (NSM).2–4 However, these benefits come with a prolonged operative time, uncertainty surrounding its oncologic safety, and potentially increased costs. Recently, Toesca et al5 reported outcomes from the first randomized controlled trial comparing RNSM to open NSM. Among 80 women with breast cancer or a BRCA mutation, RNSM took significantly longer but produced better quality of life for patients after surgery as determined by the Breast-Q and Body Image Scale instruments. Overall, postoperative complications were equivalent between study arms, but no skin or nipple necrosis was observed for the 40 patients that underwent RNSM compared with 12.5% of patients after open NSM. Long-term follow-up with comparisons of oncologic outcomes is expected in a future report. While RNSM may relieve some of the technical challenges to traditional NSM and provide superior cosmetic outcomes, concerns over safety and effectiveness remain due to lack of long-term data on local disease recurrence, disease-free survival, and overall survival. As a response to the rising number of RNSMs performed in community hospitals and outside of a clinical trial setting, the U.S. Food and Drug Administration (FDA) issued a safety communication in early 2019 directed towards patients with or at high risk of developing breast cancer and health care providers that were performing RNSM.6 As the first step to addressing these concerns, we opened the first US investigator-initiated clinical trial assessing the safety, efficacy, and potential risks of RNSM with the daVinci Xi surgical system.7 While the technical details of performing RNSM has been reported previously, prior studies did not discuss the logistics of implementing a successful new Robotic Breast Operation (RoBO) program. In this article, we discuss the development and implementation of a RoBO program (Table 1). TABLE 1. - Process for Implementation of a Robotic Breast Operation Program Task 1. Apply for investigator device exemption approval from the FDA 2. Engage multiple stakeholders throughout the institution 3. Develop technical expertise required to perform robotic-assisted breast surgery in a safe and timely fashion a. Obtain foundational robotic skills via modules and bedside assisting other robotic procedures b. Perform breast surgery on cadaver models i. Include key intraoperative personnel in the exercise to perform all aspects of the procedure including positioning, robotic device docking, port placement, instrument exchanges, robotic device undocking, and specimen removal 4. Establish team members and responsibilities a. Involve the same operative personnel whenever possible to establish familiarity with roles and responsibilities 5. Schedule the first case a. Optimal patient selection is important b. Transparent discussion with the patient regarding equipoise and experiemental nature of the procedure in addition to the risks/benefits with study participation 6. Monitor outcomes and provide feedback to team members for performance improvement a. Provide feedback to patients and team members 7. Communicate with oversight—FDA and IRB—especially regarding adverse events 8. Publish and disseminate the data for peer review and critique FDA indicates U.S. Food and Drug Administration; IRB, Institutional Review Board. REGULATORY CONCERNS Persistent concerns about the performance of off-labeled use of robotic-assisted mastectomy led to an updated FDA safety communication.8 Clinical trials conducted to investigate a new intended use of an already approved device requires FDA oversight. Study sponsors are expected to obtain FDA approval of investigator device exemption (IDE) if a study involves the use of a “significant risk device.” Thus, while the da Vinci robotic Si and Xi platforms do have 510(k) clearance by the FDA, for trials evaluating its role for mastectomy procedures, an IDE is required since this procedure is considered a new indication. Investigators can obtain an IDE by following the process outlined on the FDA website: https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide. Once IDE approval has been granted by the FDA, investigators can apply for local institutional review board approval for the study. ENGAGE STAKEHOLDERS To develop, launch, and maintain a successful RoBO program, it is important to engage stakeholders early. Identifying and engaging team members at various levels will help address issues before they become significant barriers. Aside from the breast and plastic surgeons, stakeholders should include administrative leaders from the operating room, surgical department, or division. Given the potential additional operative time and cost associated with performing RNSMs, engaging administrative leaders early and often in the process may help mitigate these concerns that arise while establishing a RoBO program. Additional stakeholders may include operative personnel such as surgical technologists and circulating nurses, surgical scheduling team members, private or industry personnel (ie, Intuitive representative), research team members, or patient advocates. SURGEON TRAINING For surgeons not familiar with the basic principles of NSM, they should start out with training in open NSM. For example, there are opportunities for training in open NSM through the American Society of Breast Surgeons oncoplastic course. If the breast surgeon has not trained previously in robotic surgery, the surgeon should start by obtaining additional basic training in operating a robotic device. Surgeons not already performing robotic surgery for other indications should consult their hospital credentialing committee for clarification on robotic credentialing. This can help guide the training and proctoring needed to obtain credentialing to independently performing the operation. To the novice robotic surgeon, we suggest that, at minimum, the training should entail online didactics, virtual reality simulation, dry lab simulation, and, ultimately, the Intuitive certification course, which includes an animal lab. The local Intuitive representative can often help coordinate these training sessions. After obtaining sufficient proficiency in the general use of the robotic device, the surgeon should observe a live RNSM procedure then perform at least 1 RNSM on a female cadaver.9 If the breast surgeon is not experienced with robotic surgery, a trained robotic surgeon should be recruited to proctor at the console while the breast surgeon gains experience during the early portion of the learning curve. The proctor does not need to be trained in the specifics of RNSM as the main role for proctoring is to assure safe handling of the robotic device. A trained robotic proctor can be especially helpful in troubleshooting issues such as instrument clashes as the robotic arms will be confined to a tight space during certain portions of the operation. A hospital wide curriculum is in place at The Ohio State Wexner Medical Center to obtain a training certificate in robotic surgery. The curriculum includes general and specialty-specific online training modules, bedside assisting, as well as dry and wet lab experience. The qualifications for robotic-assisted surgery privileges at our institution includes completion of an accredited residency or fellowship training program in a surgical specialty or obstetrics/gynecology, documentation of completion of formal robotic training, and completion of at least 5 proctored cases with satisfactory outcomes. BUILDING A RoBO TEAM A seasoned surgical team with robotic experience provides invaluable assistance during the early portion of the surgeon’s learning curve. Coordination, cooperation, and communication between the robotic first assist, circulator, scrub tech, and anesthesia team are critical for safe robotic surgery. Basic principles in docking, undocking, and proper use of robotic instruments must be adhered to by the surgical team to assure a safe operation. A bedside assistant with breast surgery experience (eg, another breast surgeon or plastic surgeon) is critical to optimize intraoperative communication during the dissection until the operating surgeon has achieved sufficient experience performing RNSM. For reconstruction post RNSM, the team should include an experienced plastic surgeon comfortable with implant or tissue expander placement through axillary incision. When possible, team members should perform in a wet lab together to better understand crucial aspects of a successful operation that optimizes patient safety and outcomes including room set up, patient positioning, console docking/undocking, and challenging technical aspects of the procedure. Prior to our first live case, 5 cadaveric RNSM were performed by the same breast surgeon, plastic surgeon, and registered nurse first assist.10 Prior to the first patient, our RoBO team met to simulate a “dry run” of the case to discuss patient positioning, room set up, instrument set up, and the anticipated operative course. PATIENT SELECTION AND ELIGIBILITY CRITERIA As with all operations, much of the overall success can be attributed to appropriate patient selection. The ideal candidate does not smoke, has a normal body mass index, small to moderate breasts without ptosis, an early-stage breast cancer without nodal involvement, or the patient requires the procedure for risk reduction.11 Finally, surgeons need to be transparent with patients during the informed consent process regarding the current state of robotic-assisted surgery for mastectomy as well as their own robotic experience with clear discussion of the experimental nature of the procedure. SCHEDULING A ROBOTIC CASE After the patient has been appropriately consented, surgery scheduling challenges may arise depending on the institutional policy regarding access to robotic devices. If the robotic device availability and operating room availability are coordinated separately (eg, having a robot available does not necessarily mean an available operating room), additional organizational efforts may be required. Having an available robot, operating room, breast surgeon, and reconstructive surgeon on the same day may pose scheduling challenges such that the time from the decision to perform robotic-assisted surgery to the actual operation may be unacceptable for a patient with an active cancer diagnosis. CONCLUSIONS Breast surgeons continue to evolve the mastectomy from the debilitating and disfiguring radical approach performed by Halsted at the turn of the 20th century to the more cosmetically appealing mastectomies of today without compromising oncologic principles. RNSM offers an exciting next step in this evolution with promising benefits to both patient and surgeon. Surgical technical innovation is inevitable and necessary to ultimately provide the best patient outcomes. However, adherence to rigorous safety guidelines, transparency, and independent oversight are foundational to assure the highest level of excellence and safety for our patients.

Indocyanine Green Fluorescence-Guided Surgery for Gastrointestinal Tumors: A Systematic Review

Abstract: Objective: To conduct a systematic review of the currently available literature on the use of ICG to guide surgical dissection in gastrointestinal (GI) cancer surgery. Background: Real-time indocyanine green (ICG) fluorescence-guided surgery has the potential to enhance surgical outcomes by increasing patient-tailored oncological precision. Methods: MEDLINE, PubMed, EMBASE, and Google Scholar were searched for publications on the use of ICG as a contrast agent in GI cancer surgery until December 2020. Perfusion studies were excluded. Quality of the studies was assessed with the Methodological Index for nonrandomized Studies or Jadad scale for randomized controlled trials. A narrative synthesis of the results was provided, with descriptive statistics when appropriate. Results: Seventy-eight studies were included. ICG was used for primary tumor and metastases localization, for sentinel lymph node detection, and for lymph flow mapping. The detection rate for primary colorectal and gastric tumors was 100% after preoperative ICG endoscopic injection. For liver lesions, the detection rate after intravenous ICG infusion was 80% and up to 100% for lesions less than 8 mm from the liver surface. The detection rate for sentinel lymph nodes was 89.8% for esophageal, 98.6% for gastric, 87.4% for colorectal, and 83.3% for anal tumors, respectively. In comparative studies, ICG significantly increases the quality of D2 lymphadenectomy in oncological gastrectomy. Conclusion: The use of ICG as a guiding tool for dissection in GI surgery is promising. Further evidence from high-quality studies on larger sample sizes is needed to assess whether ICG-guided surgery may become standard of care.

Minimum Esophageal Resection Length to Ensure Negative Proximal Margin in Total Gastrectomy for Gastric Cancer

Abstract: In Brief Objective: To identify the minimum length of esophageal resection to ensure a pathologically negative proximal margin (PM) in total gastrectomy for gastric cancer. Background: In total gastrectomy, a certain esophageal length is resected to obtain a pathologically negative PM because of the possibility of unexpected pathological esophageal invasion. However, a recommendation regarding the esophageal transection site in total gastrectomy has not been established. Methods: The data of patients who underwent total gastrectomy for gastric cancer from 2005 to 2018 were collected. We evaluated the length of unexpected pathological esophageal invasion (esophageal ΔPM) in each type of disease and each location of the gross proximal tumor boundary (PB) using the length between the PB and the esophagogastric junction (PB-EGJ length). Results: Of the 1005 patients eligible for this study, 277, 196, and 532 had cT1, cT2–4 expansive (Exp), and cT2–4 infiltrative (Inf) growth patterns, respectively. In cT1 and Exp, no unexpected pathological esophageal invasion occurred when the PB-EGJ length was >1 cm, whereas pathological esophageal invasion occurred in 20.0% of cT1 and 32.7% of Exp when the PB-EGJ length was ≤1 cm. The esophageal ΔPM was <1 cm. In Inf, no unexpected pathological esophageal invasion occurred when the PB-EGJ length was >3 cm, whereas pathological esophageal invasion occurred in 17.4% of patients when the PB-EGJ length was ≤3 cm. The esophageal ΔPM was <2 cm. Conclusions: New recommendations regarding the esophageal resection length required to ensure a pathologically negative PM in total gastrectomy are herein proposed. Mini-Abstract: This retrospective study evaluated the length of unexpected pathological esophageal invasion in each type of disease and each location of the proximal tumor boundary of gastric cancer. New recommendations regarding the esophageal resection length required to ensure a pathologically negative proximal margin in total gastrectomy are herein proposed.

Use of a New Prevention Model in Acute Care Surgery

Abstract: Whether patients undergo the more morbid and costly emergent rather than an elective type of surgery, may depend on many factors. Since tertiary prevention (preventing poor outcomes from emergency surgery) carries a much higher mortality than secondary prevention (preventing emergency surgery) or primary prevention (preventing the disease requiring surgery), the overall United States mortality might be reduced significantly, if emergency surgery could be avoided via high-quality primary prevention and non-surgical therapy or increasing elective surgery at the expense of emergency procedures, e.g., secondary prevention. The practice and study of acute care surgery then has the potential to broaden from a focus on the patient in the hospital emergency and operating rooms to the patient who no longer requires either, whose disease is treated or prevented in his/her/their community.